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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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European Parliament Looks to Take Over EMA Fee Process

The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers.

The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers.

“Members felt that matters relating to the structure and level of [EMA] fees should be decided through the co-decision procedure rather than through implementing acts. Accordingly, they deleted the relevant parts of the text that empowered the Commission to adopt implementing acts relating to fees,” according to text adopted by Parliament on 10 March.

The amendment package also seeks to clarify how EMA is funded and operates. Members clarified and separated EMA’s sources of revenue, stating that revenue will consist of:

A contribution from the EU;

A contribution from any European third country with which the EU has agreements;

The fees paid by undertakings for obtaining and maintaining EU marketing authorisations for human and veterinary medicinal products and for other services provided by the agency;

Charges for any other services provided by EMA; and

Other sources of income, including ad-hoc grants.

The European Parliament and the Council will re-examine the level of the EU contributions on the basis of need and by taking into account the current level of fees. And in order to avoid fluctuations in fee revenue, “any positive budget outturn of a financial year will be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations.”

Meanwhile, other amendments called on EMA to develop a system for accepting alternative models for testing medicines that can be “more predictive” and “may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.”

And a report on the experience acquired through the amending of this regulation will be published every five years (rather than every 10 years), according to the adopted text.